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Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer (ATB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01323387
First Posted: March 25, 2011
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
  Purpose

Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.

The primary objective of this study to measure fusion success in patients with lumbar degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is evaluation of the patient's quality of life, pain and function.


Condition Intervention
Lumbar Degenerative Disc Disease Device: Interbody Fusion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lumbar Degenerative Disc Disease Treated With

Resource links provided by NLM:


Further study details as provided by Synthes USA HQ, Inc.:

Primary Outcome Measures:
  • Number of Subjects With Successful Radiographic Fusion [ Time Frame: 24 Months ]
    CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.


Secondary Outcome Measures:
  • Quality of Life Using the SF-12 Scale Physical Health Component Score (PCS). Number of Subjects Who Achieved 15% Improvement in PCS Compared to Baseline. [ Time Frame: 24 Months ]
    Quality of Life using the SF-12 Scale Physical Health Component Score (PCS). The PCS is a measurement of health status with a range of 0-100. A higher score indicates less disability.

  • Pain Scores on the Numeric Rating Scale (NRS) [ Time Frame: Baseline and 24 Months ]
    The Numeric Rating Scale (NRS) is a measurement of pain from a value of 0 (no pain) to a value of 10 (worst pain)

  • Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline [ Time Frame: 24 Months ]
    The outcome measure is the number of subjects who achieved a 15% improvement in ODI compared to baseline. The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. ODI scores range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible

  • Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline [ Time Frame: Baseline and 24 Months ]
    The outcome measure is the number of subjects who achieved a 15% improvement in MCS compared to baseline. The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.

  • SF-12 Physical Composite Score (PCS) Summary [ Time Frame: Baseline and 24 Months ]
    The PCS (Physical Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.

  • SF-12 Mental Composite Score (MCS) Summary [ Time Frame: Baseline and 24 Months ]
    The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.

  • Oswestry Disability Index (ODI) Summary [ Time Frame: Baseline and 24 Months ]
    The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The scores can range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible


Enrollment: 178
Actual Study Start Date: April 1, 2004
Study Completion Date: February 1, 2011
Primary Completion Date: May 1, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment
Interbody fusions with Anterior Plating
Device: Interbody Fusion
allograft spacer + anterior plate
Other Names:
  • ATB
  • Anterior Tension Band

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. One or Two level (consecutive) degenerative disc disease between L2 and S1. Degenerative disc disease is defined as follows:

    Chronic pain (confirmed by patient exams and history) of discogenic origin, confirmed by radiographic evidence (e.g. MRI, discogram) two or more of the following:

    • Modic type 2 endplate changes on T2 weighted MRI
    • high intensity zone signal on T2 weighted MRI
    • positive discogram with negative controls
    • dark disc (diminished T2 weighted signal)
    • decreased disc height
  2. Has experienced pain, functional deficit and/or neurological deficit for a minimum six month period of time prior to enrollment
  3. Has failed to respond to non-operative treatment modalities for a minimum three month period of time prior to enrollment
  4. Skeletally mature and at least 18 years of age
  5. Signs the approved Informed Consent Document
  6. Is available for long term follow-up and interval visits

Exclusion Criteria:

  1. Has more than 2 levels to be instrumented
  2. Has had a previous fusion attempt at the involved level(s)
  3. Has had more than two previous open, lumbar spine surgical procedures at the involved level(s)
  4. Currently implanted with anterior instrumentation at the involved level(s)
  5. Patient would be classified as morbidly obese BMI > 35
  6. Active localized or systemic infection
  7. Presence of a disease entity or condition which significantly affects the possibility of bony fusion (e.g., osteoporosis, metastatic cancer, long-term use of steroids, etc.)
  8. Has an immunosuppressive disorder
  9. Pregnant or interested in becoming pregnant during the study.
  10. Has a known sensitivity to device materials
  11. Mentally incompetent or prisoner
  12. Currently a participant in another study for the same indications.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323387


Sponsors and Collaborators
Synthes USA HQ, Inc.
Investigators
Principal Investigator: Kirkham Wood, MD Mass. General Hospital
  More Information

Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT01323387     History of Changes
Other Study ID Numbers: 1255
First Submitted: March 23, 2011
First Posted: March 25, 2011
Results First Submitted: December 6, 2016
Results First Posted: May 17, 2017
Last Update Posted: October 18, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases